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File No: NA/733
July 1999
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION
AND ASSESSMENT SCHEME
FULL PUBLIC REPORT
Component in OGA 574
This Assessment has been compiled in accordance with the provisions of the Industrial
Chemicals (Notification and Assessment) Act 1989 (the Act) and Regulations. This
legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals
Notification and Assessment Scheme (NICNAS) is administered by the National
Occupational Health and Safety Commission which also conducts the occupational health &
safety assessment. The assessment of environmental hazard is conducted by the Department
of the Environment and the assessment of public health is conducted by the Department of
Health and Aged Care.
For the purposes of subsection 78(1) of the Act, copies of this full public report may be
inspected by the public at the Library, National Occupational Health and Safety Commission,
92-94 Parramatta Road, Camperdown NSW 2050, between the following hours:
Monday - Wednesday
Thursday
Friday
8.30 am - 5.00 pm
8.30 am - 8.00 pm
8.30 am - 5.00 pm
Copies of this full public report may also be requested, free of charge, by contacting the
Administration Coordinator on the fax number below.
For enquiries please contact the Administration Coordinator at:
Street Address: 92 -94 Parramatta Rd CAMPERDOWN NSW 2050, AUSTRALIA
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA
Telephone:
(61) (02) 9577 9514 FAX (61) (02) 9577 9465
Director
Chemicals Notification and Assessment
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NA/733
FULL PUBLIC REPORT
Component in OGA 574
1.
APPLICANT
Chevron Chemical Australia of 385 Bourke Street MELBOURNE VIC 3000 has submitted a
standard notification statement in support of their application for an assessment certificate for
Component in OGA 574.
2.
IDENTITY OF THE CHEMICAL
The chemical name, CAS number, molecular and structural formulae, and chemical
composition have been exempted from publication in the Full Public Report and the
Summary Report.
Other Names:
CP 2474, SP 2474, polybutene amine (containing 70%
the notified chemical)
Marketing Name:
OGA 574
Number-Average
Molecular Weight (NAMW):
1 209
Weight-Average
Molecular Weight (WAMW):
1 637
Polydispersity:
1.45
Maximum Percentage of Low
Molecular Weight Species
Molecular Weight < 500:
Molecular Weight < 1 000:
0%
24%
Method
of
and Determination:
Spectral Data:
3.
Detection IR, NMR
GPC (molecular weight)
Spectra of IR and NMR were provided for the identity
of the notified chemical.
PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
and 101.3 kPa:
at
20°C
Colorless to yellowish viscous liquid
Boiling Point:
Decomposes before boiling.
Specific Gravity:
0.81 g/mL at 15C
Vapour Pressure:
<1.33x10-3 kPa
Water Solubility:
< 1 ppm
Particle size:
Not applicable as notified chemical is liquid
Partition
(n-octanol/water):
Hydrolysis
of pH:
as
Co-efficient
log POW=7.1
a
Function Not determined, but expected to be stable.
Adsorption/Desorption:
Not determined, but expected adsorbed to soil strongly.
Dissociation Constant:
Will not dissociate.
Flash Point:
>189°C
Flammability Limits:
Will burn in the presence of enough heat and oxygen.
Autoignition Temperature:
>200°C
Explosive Properties:
Not known to be explosive.
Reactivity/Stability:
Will react in the presence of strong oxidising agents.
Comments on Physico-Chemical Properties
The boiling point of the notified chemical was not determined. The notifier estimates that the
chemical will have a low vapour pressure.
The water solubility of the notified chemical was not determined. However, the notifier
indicates with comparison to another chemical with known solubility that the polyisobutylene
chain of the notified chemical will make it very insoluble in water. The chemical is expected
to have a water solubility of less than 1 mg/L.
Due to the low water solubility of the notified chemical hydrolysis is unlikely in the
environmental pH range of between 4 and 9. Also the notified chemical contains no
functional groups that can hydrolyse.
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The partition coefficient log POW of the notified chemical between n-octanol and water was
estimated to be = 7.1 at 20C by a flask shaking method using reverse phase HPLC similar to
the OECD TG 107.
The determination of the adsorption/desorption coefficient of the notified chemical was not
undertaken. The notified chemical is expected to be insoluble in water and will largely
partition into n-octanol rather than water. Due to its low water solubility and surface activity,
the chemical is expected to become associated with the organic component of soils and
sediments. The notifier also indicates from studies of similar dispersant/detergent substances
to the notified chemical that the adsorption/desorption binding coefficients are in the 4050000 range.
No dissociation constant data was provided for the notified chemical. At low pH the
aromatic amine functionality will be protonated and may result in increased water solubility.
4.
PURITY OF THE CHEMICAL
Degree of Purity:
70% in aromatic solvent
Hazardous Impurities:
None
Non-hazardous Impurities
(>1% by weight):
Impurity
Polyisobutylene
CAS Number
9003-27-4
Weight %
5-10
Additives/Adjuvants:
C9 aromatic solvent (CAS no. 64742-95-6) is on the
NOHSC List of Designated Hazardous Substances with
R45(2) (May cause cancer, carcinogen category 2) and
R65 (Harmful: May cause lung damage if swallowed),
and cut-off (T%) of 0.1% (National Occupational
Health and Safety Commission, 1999).
Degradation Products:
Stable under normal conditions.
Loss of Monomers, Additives,
None expected.
Impurities:
5.
USE, VOLUME AND FORMULATION
The notified chemical is intended for use as an ingredient of a deposit control detergent/
dispersant additive in unleaded petrol. The notifier claims that the generalised effects of the
use of the notified chemical when formulated in a deposit control additive package and
subsequently used in a petrol engine are reduced exhaust emissions, improved fuel economy,
reduced engine deposits and longer engine life.
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The notified chemical will not be manufactured in Australia. It will be imported into
Australia in 8 000 L ISO containers. The new fuel additive will be shipped to Australia as a
pre-blended fuel additive, which will contain from 10-90 % w/w of the notified chemical.
Estimated import volumes for the chemical are as follows:
Year
Import Volume (tonnes)
1
100
2
200
3
300
4
400
5
500
The range of the final concentration of the notified chemical in finished petrol is expected to
be 50 to 500 ppm.
6.
OCCUPATIONAL EXPOSURE
As the notified chemical has low vapour pressure and is formulated as a viscous liquid,
exposure via inhalation is unlikely. Dermal and ocular contact will be the main routes for
occupational exposure.
Transport and Storage
Once received in Australia, the 8 000 L isotanks containing the notified chemical will be
loaded and transported by truck to approximately 5 petrol marketeers.
Exposure of workers during transport or storage of the notified component is expected to be
low except in the case of accidental spillage.
Refinery/Terminal Facility
Blending of the fuel additive package containing the notified chemical into petrol will occur
at approximately 20 petrol blending terminals. At blending site, one worker will unload the
isotanks. The worker will connect a flexible hose to the isotank and pump OGA 574 from the
isotank to a storage tank through hard piping. In order to minimise spill or leaks, the hose is
automatically pigged after the isotank is unloaded and the hose end is kept on an oily drain
when not in use. During unloading of the ISO containers, there is opportunity for incidental
skin and eye contact to splashes, drips and spills as hose and pipe connections are made or
broken. The worker will wear protective clothing, rubber gloves, safety glasses and a hard
hat.
A sampling worker will take samples of OGA 574 from the storage tank on its arrival for
analysis. Exposure via skin and eye may occur during the sampling. The worker will wear
eye protection, protective clothing, rubber gloves and a hard hat. Samples will be analysed
by laboratory personnel.
Automatic computer controlled inline blenders are used for mixing the fuel additive package
with petrol. The components for the blend are drawn directly and automatically from their
storage tanks, blended then sent back to another product storage tank. Occupational exposure
during blending is not expected to occur except in the case of accidental spillage.
After blending, one worker will take samples from the product storage tank for analysis.
Dermal or ocular exposure may occur during the sampling. The worker will wear eye
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protection, protective clothing, rubber gloves and a hard hat. Analysis will be carried out in a
laboratory by a laboratory staff.
Once the final petrol is blended, distribution to petrol service stations and other commercial
petrol sales outlets will occur by tank truck. Transportation workers are likely to have access
to engineering controls and wear protective clothing.
Petrol Service Stations
Attendants at the petrol service stations will receive the petrol by pumping it through a hose
to the storage tanks. They may add the petrol into customers’ automotive fuel tanks. Some
dermal exposure to the notified chemical may occur but this is expected to be at very low
levels due to its low concentration in petrol (50-500 ppm). Engine mechanics may come into
contact with petrol while working on the fuel system of automotive engines. Engine
mechanics and petrol station attendants usually have protective clothing.
7.
PUBLIC EXPOSURE
There is potential for exposure of the public to the notified chemical who pump gasoline into
automotive fuel tanks. The most likely means of exposure to the notified chemical is skin
and eye contact. Consumers at petrol stations seldom wear gloves or other protective
equipment. However, the public exposure is expected to be low.
8.
ENVIRONMENTAL EXPOSURE
Release
After importation by sea the notified chemical will be transported via road without
repackaging in the closed 8 000 L isotanks; potential release would only be through
accidental spills. The material safety data sheet (MSDS) details procedures to protect the
environment in these cases. Once received by the customers, the isotanks are emptied via a 2
to 2.5 metre flexible hose. After the isotank is unloaded the hose is automatically pigged to
the isotank. The notifier indicates that during this procedure the amount of material lost due
to spills and leaks is less than 50 mL per load, which is 5 to 45 g of the notified chemical.
The empty isotanks are not cleaned in Australia, but shipped back to the USA.
The same 50 mL volume of loss due to spills and leaks is also possible when transport
tankers are filled with the final blended fuel product. This loss would also occur at petrol
service stations when tankers are emptied into storage tanks. In both these cases given its
low percentage in fuel, the loss of notified chemical in these spills would be expected to be
low.
There is no data available that takes into account the frequent minor spills (< 1 L) that would
occur at petrol bowsers as customers fill their vehicles with fuel. However, given its low
percentage in fuel, the loss of notified chemical in these spills would be expected to be low.
The notifier also indicates that the petrol when spilled will evaporate leaving the fuel additive
containing the notified chemical behind. The notified chemical will then bind strongly to the
soil, concrete and asphalt and, coupled with a low water solubility, aquatic pollution should
not be significant.
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The intended use pattern of the notified chemical in the fuel additive is not expected to result
in a significant release to the environment as it is claimed by the notifier to be destroyed by
combustion within the petrol engine. The notifier indicates that small amounts may make it
into the crankcase of a combustion engine in blown-by gases. Once in crankcase used oil the
notified chemical will continue to act as an ashless type dispersant providing increased
performance. There is no direct data to support the claim of complete combustion of the
chemical to oxides of carbon, nitrogen and hydrogen when the fuel is burnt within the
combustion chamber of petrol engines. The notifier states that the complete combustion of
the chemical is essentially an intuitive assumption. It is noted that the chemical is made up of
hydrocarbon and oxygen, the normal constituents of the petrol, and a small amount of
nitrogen. The notified chemical will be a minute part of fuel and should not survive the
temperatures at which the fuel is exploded within the internal combustion engine.
The chemical and additive package will not be directly marketed to the public, but preblended into the petrol to be sold at service stations.
Fate
If the notified chemical is released to soil in either a spill or leak from a storage tank, it is
expected to bind strongly to soil due to its low water solubility and high partition coefficient
of 7.1. If released to an aquatic environment, the chemical would tend to partition out of
water and into sediment. Once adsorbed to soil/sediment, the fate of the chemical is
unknown. However, the ready biodegradability of the notified chemical was examined by
exposure to activated sewage sludge microorganisms at a concentration of 10 mg/L at 21°C
for 28 days. Degradation of the notified chemical was assessed by the determination of
carbon dioxide produced. A degradation of 9.7% was attained after 28 days, so the notified
chemical cannot be considered to be readily biodegradable under the terms and conditions of
the Modified Sturm Test OECD TG 301B.
The chemical is not expected to cross biological membranes, due to the low solubility and
high molecular weight, and should not bioaccumulate (Connell, 1989).
The notifier provides no data concerning the effect of the notified chemical on tail pipe
emissions. The notifier supplies a report published by the EPA (US EPA Office of Air and
Radiation & Office of Mobile Sources, 1994) on the benefits of deposit control additives like
the notified chemical in controlling tail pipe emissions and improving fuel economy.
Discussions on test results provided show a statistical difference in HC, CO and NOx
emissions between test fuel with and without the fuel additive. The long term result of
detergent fuel additives is to both reduce the formation of engine deposits, i.e. “keep clean”,
and “clean up” existing engine deposits leading to reduced levels of tail pipe emissions.
In combination with certain detergent/dispersant additives, the notified chemical is said by
the notifier to be registered and approved for use with the US EPA as a fuel additive. Deposit
control additives such as OGA 499 are said to be mandated by the US 1990 Clean Air Act
because of their recognised ability to control the formation of port fuel injector deposits and
intake valve deposits.
9.
EVALUATION OF TOXICOLOGICAL DATA
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In all toxicological studies submitted, the test substance was CP 2474, which is 70% notified
chemical in C9 aromatic solvent (CAS no. 64742-95-6).
9.1
Acute Toxicity
Summary of the acute toxicity of CP 2474
Test
Species
Outcome
Reference
acute oral toxicity
rat
LD50> 5 000 mg/kg
(Glaza, 1998b)
acute dermal toxicity
rat
LD50> 2 000 mg/kg
(Glaza, 1998a)
skin irritation
rabbit
Slight to moderate irritant
(Glaza, 1998c)
eye irritation
rabbit
Slight to moderate irritant
(Glaza, 1998d)
skin sensitisation
guinea pig
Not sensitising
(Morris, 1998)
9.1.1 Oral Toxicity (Glaza, 1998b)
Species/strain:
Rats/Cr1:CD(SD)BR
Number/sex of animals:
5/sex
Observation period:
14 days
Method of administration:
Oral (gavage), single dose of 5 000 mg/kg
Test method:
Limit test, OECD TG 401
Clinical observations:
Clinical signs of red-stained face and yellow-orangestained/wet urogenital area were observed after treatment;
all animals recovered by day 4.
Mortality:
None
Morphological findings:
No treatment-related effects were observed.
Comment:
None
LD50:
> 5 000 mg/kg
Result:
The test chemical was of very low acute oral toxicity in rats
9.1.2 Dermal Toxicity (Glaza, 1998a)
Species/strain:
Rats/ Cr1:CD(SD)BR
Number/sex of animals:
5/sex
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Observation period:
14 days
Method of administration:
A single dermal dose (2 000 mg/kg, undiluted) was applied
to the intact skin on each animal’s back for 24 hours under a
semi-occlusive dressing.
Clinical observations:
Slight erythema was observed in one male and one female
with slight edema in the one female. Other animals
appeared normal throughout the study.
Test method:
Limit test, OECD TG 402
Mortality:
None
Morphological findings:
No treatment-related effects were observed.
Comment:
None
LD50:
> 2 000 mg/kg
Result:
The test chemical was of low dermal toxicity in rats
9.1.3 Inhalation Toxicity
Not performed due to high viscosity.
9.1.4 Skin Irritation (Glaza, 1998c)
Species/strain:
Rabbits/Hra:(NZW)SPF
Number/sex of animals:
4 males and 2 females
Observation period:
7 days
Method of administration:
An undiluted dose (0.5 mL) was applied on each animal’s
back for 4 hours under a semi-occlusive dressing.
Test method:
OECD TG 404
Draize scores (Draize, 1959):
Time after treatment
Animal #
4 hours
1 day
2 days
3 days
4 days
7 days
2
2
1
1
0
Erythema
1
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a
2
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2
2
1
1
1
1
0
3
2
2
1
1
1
0
4
1
1
1
1
1
0
5
1
1
0
0
0
0
6
1
1
1
1
1
0
1
2
2
1
1
0
0
2
2
1
1
0
0
0
3
2
2
1
1
1
0
4
2
1
1
1
1
0
5
1
0
0
0
0
0
6
1
1
1
1
0
0
Oedema
a
see Attachment 1 for Draize scales
Comment:
Slight to well-defined erythema and very slight to slight
oedema were observed in animals. In all cases, irritation
had cleared by day 7.
Result:
The test chemical was a slight to moderate irritant to the skin
of rabbits
9.1.5 Eye Irritation (Glaza, 1998d)
Species/strain:
Rabbits/Hra:(NZW)SPF
Number/sex of animals:
5 males and 1 female (group 1), 3 females (group 2).
Observation period:
7 days
Method of administration:
An undiluted dose (0.1 mL) was applied into the right eye,
with the left eye serving as the control.
The eyes of rabbits in group 1 remained unflushed after
treatment, while the treated eyes of the group 2 rabbits were
flushed with water for 1 minute starting 30 seconds after
instillation.
Test method:
OECD TG 405
Draize scores (Draize, 1959):
Time after instillation
Animal
Conjunctiva
1 day
r
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c
2 days
d
r
c
3 days
d
r
c
4 days
d
r
c
7 days
d
r
c
d
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Group 1
(unwashed)
1
2
2
0
2
1
0
2
1
0
1
0
0
0
0
0
2
2
1
0
1
1
0
0
0
0
0
0
0
0
0
0
3
2
1
0
2
1
0
1
0
0
1
0
0
0
0
0
4
2
1
0
1
1
0
1
0
0
0
0
0
0
0
0
5
1
1
0
0
0
0
0
0
0
0
0
0
0
0
0
6
2
1
0
1
1
0
1
0
0
1
0
0
0
0
0
Group 2
(washed immediately after instillation)
7
1
1
0
1
0
0
0
0
0
0
0
0
0
0
0
8
1
1
0
1
1
0
0
0
0
0
0
0
0
0
0
9
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
see Attachment 1 for Draize scales
r = redness c = chemosis d = discharge
The Draize scores for cornea in both Groups 1 and 2 were
zero except 1 male rabbit of Group 1 had score 1 in both
degree of opacity and area of involvement at 24 hours.
The Draize scores for iris in both Groups 1 and 2 were zero.
Comment:
The results of sodium fluorescein examinations at 24 and 48
hours after treatment (for possible corneal injury) were all
negative in both Group 1 and 2, except 1 male from Group 1
had a 10% area positive stain retention at 24 hours after
treatment.
Result:
The test chemical was a slight to moderate irritant to the
eyes of rabbits
9.1.6 Skin Sensitisation (Morris, 1998)
Species/strain:
Guinea pigs/Hartley
Number of animals:
Pilot group: 4/sex,
Test group: 10/sex,
Control group: 5/sex.
Induction procedure:
test group:
day 0
day 7 and 14
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A dermal dose (0.3 mL, undiluted) was applied on the back
of each animal for 6 hours using a Hill Top Chamber which
was occluded with rubber dental dam pulled taut and
fastened with clips.
Induction was repeated as day 0.
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control group:
Not treated
Challenge procedure:
day 27
A dermal dose (50% w/v in mineral oil) was applied to a
skin site that had not been exposed previously for 6 hours
using a Hill Top Chamber.
Test method:
Buehler method, OECD TG 406
Challenge outcome:
Test animals
Challenge
concentration
50%
Control animals
24 hours*
48 hours*
24 hours
48 hours
**0/20
0/20
0/10
0/10
*
time
after
patch
removal
** number of animals exhibiting positive response (grade 1 - slight but confluent or moderate patchy
erythema).
Comment:
A pilot irritation study was performed to select the test
concentrations. Slight patchy erythema was observed in test
group after challenge and was treated as negative response
based on the similar results from the control group. Historic
data of positive controls were provided to demonstrate the
sensitivity of the test.
Result:
The test chemical was not sensitising to the skin of guinea
pigs
9.2
Repeated Dose Toxicity
9.2.1 Preliminary 5-Day Oral (Gavage) Study in Rats (Knapp, 1999)
Species/strain:
Rats/Cr1:CD(SD)BR
Number/sex of animals:
5/sex/group
Method of administration:
Oral (gavage)
Dose:
0, 100, 300, 500, and 1 000 mg/kg/day
Study duration::
5 consecutive days
Clinical observations:
All animals survived to study termination. Clinical findings
included clear matting, hair loss and soft stool, these were
limited to single animals in various dose groups. No
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significant body weight changes were observed.
Comment:
None
Result:
Based on the absence of any significant clinical observations
and finding, dose levels of 50, 250 and 500 mg/kg/day were
selected for the 28-day oral toxicity study.
9.2.2 28-Day Oral (Gavage) Study in Rats (Knapp, 1999)
Species/strain:
Rats/Cr1:CD(SD)BR
Method of administration:
Oral (gavage)
Dose:
0, 50, 250 and 500 mg/kg/day
Test method:
OECD TG 407 and 421
Subchronic toxicity phase
Number/sex of animals:
10/sex/group, 5/sex/group comprised the recovery group
Study duration::
28 consecutive days treatment, with the recovery group
having a 14-day recovery period after treatment.
Clinical observations:
No mortality occurred during the experiment. Neither bodyweight gain nor food
consumption was affected during the 28-day treatment or the 14-day recovery period. The
only treatment-related finding was clear matting around the mouth one hour after dosing in
both male and female animals at 500 mg/kg/day, primarily during weeks 2-4 of treatment.
Clinical chemistry/Haematology
No treatment-related effects were found in hematology, serum chemistry, plasma
cholinesterase levels, and urinalysis studies in any of the animals. Although, there were
some individual changes such as increase in corpuscular haemoglobin concentration,
decreases in globulin, total protein, uric acid and phosphorus in sera, they were not
considered to be related to the treatment.
Pathology:
No treatment-related effects were found in macro- and microscopic examinations in
animals with or without recovery period. Some changes such as increases in liver
weight/bodyweight in 50 mg/kg/day males, and thymus weight (absolute and relative to
bodyweight) in 250 mg/kg/day males, decrease in adrenal weight/bodyweight in male
animals at 50 mg/kg/day, were noted. However, it was concluded that they were not
related to the treatment based on the comparison with control group and other dosing
groups.
Neurotoxicity phase
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Number/sex of animals:
5/sex/group
Study duration:
28 consecutive days treatment
Clinical observations:
No mortality was observed during the treatment period. Both bodyweight gain and food
consumption were not affected by the treatment. Clear matting around the mouth one hour
following dosing in weeks 3-4 was found in all male groups (including the control group)
and females at 250 and 500 mg/kg/day. The increasing incidence in 500 mg/kg/day males
was considered to be treatment-related.
In a functional observational battery of tests, no remarkable differences were observed
between the control and treated groups in home cage, handling, open field, sensory,
neuromuscular and physiological observations. In open field observations, an increase in
the mean urination count in males at 500 mg/kg/day and a decrease in the number at a
normal state of arousal in males at 250 mg/kg/day were observed at week 2. However, no
similar differences were seen at week 4, or in the females at higher dose levels. Motor
activity was also unaffected by the treatment.
Pathology:
No treatment-related differences between the treated and control groups were found in
brain weight, brain dimensions, and microscopic examinations. One female at 500
mg/kg/day had digestion chambers (graded minimal) in the sciatic nerve and one control
male had a dilated myelin sheath in one lumbar ventral root fiber.
Reproduction phase
Number/sex of animals:
12/sex/group
Study duration:
Animals were dosed for at least 28 days prior to mating.
The males continued the treatment for a total minimum
period of 70 or 71 days. The females continued the
treatment until lactation day 4 for those which delivered a
litter, or post-mating day 25 for those which did not deliver
a litter, or 25 days after the termination of the breeding
period without evidence of mating. Females were not dosed
if parturition appeared to be in progress.
F0 Clinical observations:
No mortality was observed during the treatment period. No remarkable differences were
observed between the control and treated groups in both bodyweight gain and food
consumption at weekly check, during gestation and lactation days. Minor changes in
bodyweight and food intake were attributed to biological variation.
Similar to the findings in the subchronic and neurotoxicity studies, clear matting around the
mouth one hour following dosing primarily in weeks 1-6 was found in all groups including
the control group. It was demonstrated to be dose-related.
Reproductive performance in both treated and control animals was evaluated. The mating
and fertility indices in F0 males and females did not suggest any effects due to the
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treatment. The mean numbers of days between pairing and coitus were comparable among
the groups. Similarly, the gestation length was unaffected by treatment with the test
substance.
F0 Pathology:
One female (250 mg/kg/day) with no evidence of mating and non-pregnant was internally
normal.
Seven females (3, 3 and 1 in the control, 250, 500 mg/kg/day, respectively) were mated and
found non-pregnant from necropsy on post mating day 25. The 500 mg/kg/day female had
clear intraluminal fluid in both uterine horns. One female from 250 mg/kg/day had dark
red lungs (all lobes) and an enlarged thymus gland. One control female had white purulent
contents in the cervix and uterus. No remarkable internal abnormalities were noted in the
other 4 animals.
The remaining 40 females (9, 12, 8 and 11 in the control, 50, 250 and 500 mg/kg/day,
respectively) were necropsied (as scheduled) on lactation day 4. Although some changes
were noted in single animals and an increase in implantation sites at 250 mg/kg/day, there
were no treatment-related findings compared with the control group and historical control
data.
No treatment-related effects were observed at the scheduled necropsy in the 50, 250 and
500 mg/kg/day male groups.
Several statistically significant differences in organ weights were observed. The mean liver
weight in 500 mg/kg/d females was increased relative to control. However, when adjusted
for body weight gain, the difference was not significant.
No corresponding
histopathological findings in the liver were observed in high dose males and females.
Differences in mean adrenal weights were observed in females at 50 and 500 mg/kg/d, and
in mean kidney weights in mid-dose males. However, as these findings were not doserelated, they were attributed to biological variation.
No microscopic findings in the 50, 250 and 500 mg/kg/day groups of both sexes were
considered as treatment-related when compared to the control group.
F1 Clinical observations:
Nine pups (2, 3, 1 and 3 from the control, 50, 250 and 500 mg/kg/day, respectively) were
found dead at birth. Six pups (1, 4, 0 and 1 in the same respective groups) were missing
and presumed to be cannibalized. The general physical condition of F1 pups during the
postnatal period was similar in all groups.
The mean live litter size, pup body weights, number of pups born and percentage of males
per litter at birth and pup survival in 50, 250 and 500 mg/kg/day groups were comparable
to findings in the control group.
F1 Pathology:
No remarkable internal findings were observed in the 9 pups found dead at birth.
Malformation of unilateral microphthalmia was found in a pup in the 250 mg/kg/day group.
Some individual variations including dark red eyes, haemorrhagic ring around the iris, pale
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15 July 1999
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liver, non-fully developed ureters and renal papillae were observed in the animals from the
treated groups and the control group. No other malformations or developmental variations
were observed at any dose level.
All Studies
Comment:
Result:
9.3
The increased incidence of clear matting around the mouth
observed in all 3 phases of study was considered to be
treatment-related at the dose level of 500 mg/kg/day. It was
not considered to be a toxic effect. Minor liver weight
changes were observed at 500 mg/kg/d, however, there were
no corresponding histopathological findings. Other changes
were noted, but did not relate to the treatment.
The test chemical had a no observed effect level (NOEL) of
250 mg/kg/day based on the incidence of clear matting
around the mouth, and a no observed adverse effect level
(NOAEL) of 500 mg/kg/day based on the absence of
systemic toxicity in all 3 phases of the study.
Genotoxicity
9.3.1 Salmonella typhimurium and Escherichia coli Reverse Mutation Assay (Lawlor,
1998)
Strains:
Salmonella typhimurium TA98, TA100, TA1535 and
TA1537; Escherichia coli WP2uvrA
Concentration range:
33.3, 100, 333, 1 000, 3 300 and 5 000 g/plate in the
presence and absence of S9 metabolic activation (vehicle:
Pluronic F127, 25% w/w in ethanol).
Test method:
OECD TG 471/472
Comment:
The concentrations and vehicle were selected from results in
the preliminary range-finding tests. Precipitation was
observed at 1 000 g/plate. Cytotoxicity was observed at
5000 g/plate without S9 mix in Salmonella strains in one
of the two experiments.
The positive controls had
appropriate responses in the studies.
The test chemical did not cause a positive increase in the
number of revertants of any the tester strains in the absence
or presence of S9 mix under the test conditions.
Result:
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NA/733
The test substance was not mutagenic in S. typhimurium and
E. coli in the reverse mutation assay.
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9.3.2 Micronucleus Assay in the Bone Marrow Cells of the Mouse (Curry, 1998)
Species/strain:
Mouse/Cr1:CD-1(ICD)BR
Number and sex of animals:
6/males/dose group in the main test.
Doses:
24 hour harvest: 0 (vehicle), 500, 1 000 and 2 000 mg/kg;
48 hour harvest: 0 (vehicle) and 2 000 mg/kg;
vehicle: peanut oil
The doses were based on the results of two preliminary
range-finding tests, where 2 000 mg/kg was the maximum
tolerated dose.
Method of administration:
Single IP injection
Test method:
OECD TG 474
Comment:
In the main study, the test chemical did not cause clinical
toxicity in treated animals and was not cytotoxic to bone
marrow (no increase in ratio of polychromatic erythrocytes
to normochromatic erythrocytes (PCE:NCE)).
No
significant increase in micronucleated PCEs occurred at any
of the harvest intervals.
The positive controls had
appropriate responses in the studies.
Result:
The test chemical was negative in the mouse bone marrow
micronucleus assay under the study conditions.
9.3.3 Chromosomal Aberration Study in Chinese Hamster Lung Cells (Murli, 1998)
Strains:
Chinese hamster lung (CHL) cells
Concentration range:
Initial trial: 8 doses in the range 7.85–1 000 g/mL in both
the absence and presence of S9 metabolic activation (6 hour
treatment, 24 hour harvest).
Confirmatory trial:
10 doses in the range 0.505-60.5 g/mL (without S9, 21.8
hour treatment, 24 hour harvest or 45.8 hour treatment, 48
hour harvest);
8 doses in the range 6.06-60.5 g/mL (with S9, 6 hour
treatment, 48 hour harvest).
Vehicle: test chemical was dissolved in cyclohexane and
mixed 1:1 with 10% Pluronic F-68 in water.
Test method:
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OECD TG 473
15 July 1999
17/25
Comment:
Initial trial
Precipitate was observed at 62.5 g/mL. In the initial trial,
cytotoxicity was observed at 15.7 and 31.3 g/mL without
S9 mix and 31.3 g/mL with S9 mix. The assay was
negative for chromosomal aberration, polyploidy and
endoreduplication.
Confirmatory trial
Precipitate was observed at 45.4 g/mL. Cytotoxicity was
observed at 60.5 g/mL in the 24 hour assay, 15.2 g/mL in
the 48 hour assay without S9 mix, and at 25.3 g/mL with
S9 mix.
The assay was negative for chromosomal
aberration, polyploidy and endoreduplication.
The positive controls had appropriate responses in the
studies.
Result:
9.4
The test chemical did not induce chromosomal aberrations
in CHL cells with and without S9 metabolic activation under
the experimental conditions.
Overall Assessment of Toxicological Data
The toxicological studies were performed with CP 2474 which contained polybutene amine
and C9 aromatic hydrocarbon solvent.
The test chemical was of very low acute oral toxicity (LD50>5 000 mg/kg) and low acute
dermal toxicity (LD50>2 000 mg/kg) in rats. It was a slight to moderate skin and eye irritant
in rabbits. It was not a skin sensitiser in guinea pigs.
A 28-day repeat oral dose study in rats included subchronic toxicity (including 14-day
recovery period), neurotoxicity and reproductive toxicity phases. The increased incidence of
clear matting around the mouth one hour after dosing in both male and female animals was
determined to be dose-dependent. Some minor clinical or pathological changes were noted in
the study including mean liver weight changes in high dose females, however, they were
attributed to biological variation. No remarkable subchronic, neurotoxic or reproductive
effects were found to be related to the treatment with the test substance. CP 2474 had a
NOEL of 250 mg/kg/day based on the incidence of clear matting around the mouth, and a
NOAEL of 500 mg/kg/day, based on the absence of systemic toxicity in all phases of the
study.
Three genotoxicity studies were provided. The test chemical was not mutagenic in the S.
typhimurium or E. coli strains in an Ames assay. In a chromosome aberration assay in CHL
cells, both with and without metabolic activation, and in an in vivo mouse bone marrow
micronucleus assay, the test substance was negative. The test chemical was found to be
cytotoxic in the in vitro studies. In particular, the chromosome aberration assay was severely
hampered by high toxicity and heavy precipitation of the test material.
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NA/733
15 July 1999
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According to the NOHSC Approved Criteria for Classifying Hazardous Substances (National
Occupational Health and Safety Commission, 1999), CP 2474 is not classified as a hazardous
substance.
10.
ASSESSMENT OF ENVIRONMENTAL EFFECTS
The notifier has supplied ecotoxicity studies that were summarised in the following table.
The tests were performed in compliance with OECD/EEC Test Methods and according to
OECD Principles of Good Laboratory Practices.
Ecotoxicity Test Results
Test
Species
Test concentrations
Results
(nominal) mg/L
(nominal) mg/L
Acute Toxicity (Static Rainbow
trout 60, 100, 150, 250 & 96 h LC50 = 220
Test) (OECD TG 203)
Oncorhynchus
400
96 h NOEC = 60
mykiss
Acute
Toxicity
– Water Flea
130, 220, 360, 600 & 48 h EC50 = 490
Immobilisation
(Static (Daphnia magna) 1 000
48 h NOEC = 220
Test) (OECD TG 202)
Growth Inhibition
Green Algae
Growth () & Biomass (b) (Selenastrum
(Static Test) (OECD TG capricornutum)
201)
Respiration Inhibition
(OECD TG 209)
17, 33, 65, 130, 250 EµC50 > 500
& 500
EbC50 = 200
NOEC = 65
Activated Sludge 650, 1 300, 2 500, 3 h EC50 > 10
-Aerobic Waste 5000 & 10 000
000
Water Bacteria
Fish
Rainbow trout were exposed to Water Accommodated Fractions (WAFs) of the notified
substance at nominal loading rates of 60, 100, 150, 250 and 400 mg/L for a period of 96
hours under semi-static test conditions. WAFs were obtained by stirring the notified test
material at the above nominal concentrations for 24 hours followed by standing for 4 hours
prior to removal of the aqueous phase. Based on these nominal loading rate WAFs the 96
hour LC50 was determined to be 220 mg/L with 95% confidence limits of 93-140 mg/L. The
no observed effect concentration was found to be the 60 mg/L loading rate WAF. Fish
exposed to all tested WAF concentrations exhibited a change in colour, loss of equilibrium,
lethargy, and immobilisation. The concentration, homogeneity and stability of the test
material in the test solutions were not determined.
Aquatic Invertebrates
After 48 hours exposure of the notified chemical to Daphnia magna the EC50 was determined
to be 490 mg/L. No immobilisation and no other signs of intoxication were observed in
Daphnia magna at the WAF concentration of 220 mg/L. WAFs were made according to the
method outlined above.
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15 July 1999
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Algae
After 96 hours exposure of the notified chemical to green algae Selenastrum capricornutum
the EµC50 was determined to be greater than 500 mg/L and the EbC50 was determined to be
200 mg/L. The no observed effect concentration at 96 hours was determined to be the 65
mg/L WAF concentration. WAFs were made according to the method outlined above.
Microorganisms
The effect of the notified chemical on the respiration of activated sewage sludge
microorganisms was studied. A 3 hour EC50 of greater than 10 000 mg/L was determined.
The notified test substance did not inhibit respiration of the activated sludge in the tested
concentrations. However, insoluble test material was observed floating on the surface of the
test media in all non-control test vessels throughout the study.
Conclusion
The ecotoxicity data for the notified substance suggests that it is practically non-toxic to fish,
aquatic invertebrates, algae and microorganisms. However, the studies on fish, daphnia and
algae all use WAFs which could very well have much lower test substance concentrations,
due to low water solubility, than the nominal ones provided. This is confirmed by Total
Organic Carbon Analyses carried out by the notifier for the fish and daphnia studies. The
results indicate that on average only 1-3 mg/L of the notified component is found within any
given WAF irrespective of the starting nominal concentration. The test substance is,
therefore, likely to be at least slightly toxic to fish, algae and possibly daphnia.
11.
ASSESSMENT OF ENVIRONMENTAL HAZARD
The intended use pattern of the notified chemical in the fuel additive is not expected to result
in a significant release to the environment as it is claimed to be completely destroyed by
combustion within the petrol engine, resulting in oxides of carbon, nitrogen and hydrogen. In
the event of spills, the MSDS of the additive package containing the chemical contains
information on procedures to enable clean up operators to reduce release to the environment.
There is no direct data to support the claim of complete combustion of the chemical to oxides
of carbon and hydrogen when the fuel is burnt within the combustion chamber of petrol
engines. However, it is evident that the chemical and other constituents of petrol also made
up of hydrocarbon and oxygen, will be a minute part will not survive the temperatures at
which the fuel is exploded within the internal combustion engine.
Given the above, environmental exposure and the overall environmental hazard is expected to
be low.
12.
ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS
Toxicological studies were provided with a test chemical containing 70% notified chemical in
C9 aromatic solvent. It had low acute oral and dermal toxicity, was a slight to moderate skin
and eye irritant but not a skin sensitiser. It did not exhibit evidence of systemic toxicity,
neurotoxicity or reproductive toxicity in a combined oral repeated dose rat study (with a
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NA/733
15 July 1999
20/25
NOAEL of 500 mg/kg/day). It was not mutagenic or genotoxic in bacteria, Chinese hamster
lung cells or mouse bone marrow cells. On the data available, the test chemical is not a
hazardous substance according to NOHSC Approved Criteria for Classifying Hazardous
Substances (National Occupational Health and Safety Commission, 1999).
Occupational Health and Safety
Dermal and ocular contamination will be the main routes for occupational exposure to the
notified chemical. Inhalation will be a minor route of exposure given the high viscosity and
low vapour pressure of the notified chemical. Skin absorption is unlikely due to the high
molecular weight of the chemical.
The transfer and blending operations at the refinery/terminal facilities are largely enclosed
and automatically operated. However, workers at the storage sites could be contaminated
with the notified component when connecting and disconnecting hoses and during sampling
for laboratory analysis. There is therefore the potential for skin and eye irritancy during these
operations. Repeated or prolonged contact to OGA 574 may cause dermatitis. This risk of
these effects is expected to diminish in the final petrol mix due to the low concentration of
notified chemical added (50-500 ppm). Workers at these sites will need to wear appropriate
protective equipment to minimise exposure the chemicals they handle. Under these
circumstances, the risk of adverse health risks arising from possible exposure to the notified
chemical is expected to be low for these workers.
The health risk in transport workers is considered to be low given that exposure may only
occur in the event of accidental spillage. Transportation workers are likely to have access to
engineering controls and wear protective clothing to eliminate exposure. Since petrol
products are classified as dangerous goods class 3, personal protective and safety equipment
such as chemically resistant gloves or gauntlets, and electric torch should be carried on road
vehicles according to the ADG code.
Engine mechanics and petrol station attendants will handle petrol products containing low
concentrations of the notified chemical. Some skin or eye exposure may occur but expected
to be at low levels. Therefore, the health risk is low.
Public Health
There is potential for public exposure to the notified chemical arising from its use as a fuel
additive in gasoline, but the low exposure indicates a negligible risk to public health.
13.
RECOMMENDATIONS
To minimise occupational exposure to OGA 474, the following guidelines and precautions
should be observed:

Workers should be advised of the potential of occupational dermatoses following
repeated skin exposure to the notified chemical and to report any skin changes to the
occupational health and safety officer at their workplace. When an occupational skin
disease occurs, work practices and opportunities for contact with the substance should
be reviewed and preventive measures instigated to ensure other workers do not
develop the same condition. Further guideline on preventing the occurrence of
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15 July 1999
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occupational skin disease can be found in the NOHSC guide Occupational Diseases
of the Skin (National Occupational Health and Safety Commission, 1990).

Safety goggles should be selected and fitted in accordance with Australian Standard
(AS) 1336 (Standards Australia, 1994) to comply with Australian/New Zealand
Standard (AS/NZS) 1337 (Standards Australia/Standards New Zealand, 1992);

Industrial clothing should conform to the specifications detailed in AS 2919
(Standards Australia, 1987) and AS 3765.1 (Standards Australia, 1990);

Impermeable gloves should conform to AS/NZS 2161.2 (Standards Australia, 1978);

All occupational footwear should conform
Australia/Standards New Zealand, 1994);

Spillage of the notified chemical should be avoided. Spillages should be cleaned up
promptly with absorbents which should be put into containers for disposal;

Good personal hygiene should be practised to minimise the potential for ingestion;

A copy of the MSDS should be easily accessible to employees;
to
AS/NZS
2210
(Standards
If the conditions of use are varied, such as the concentration in petrol is increased, greater
exposure of the public may occur. In such circumstances, secondary notification may be
required to assess the hazards to public health.
The notified chemical will need to be tested to ensure that it will meet the upcoming criteria
in the Australian Standard, Evaluation of Devices and Additives which Claim to Improve
Vehicle Performance, to be AS 4430.2.
14.
MATERIAL SAFETY DATA SHEET
The MSDS for OGA 574 was provided in a format consistent with the National Code of
Practice for the Preparation of Material Safety Data Sheets (National Occupational Health
and Safety Commission, 1994).
This MSDS was provided by the applicant as part of the notification statement. It is
reproduced here as a matter of public record. The accuracy of this information remains the
responsibility of the applicant.
15.
REQUIREMENTS FOR SECONDARY NOTIFICATION
Under the Act, secondary notification of the notified chemical shall be required if any of the
circumstances stipulated under subsection 64(2) of the Act arise. No other specific
conditions are prescribed.
16.
REFERENCES
FULL PUBLIC REPORT
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15 July 1999
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Connell DW (1989) General characteristics of organic compounds which exhibit
bioaccumulation. In: D. W. Connell ed. Bioaccumulation of Xenobiotic Compounds. CRC
Press, Boca Raton.
Curry P (1998) Mutagenicity test on CP 2474 in the in vivo mouse micronucleus assay,
Project No. 18980-0-455CO, Covance Laboratories Inc, Vienna, Virginia, USA.
Draize JH (1959) Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.
Association of Food and Drug Officials of the US, 49: 2-56.
Glaza S (1998a) Acute dermal toxicity study of CP 2474 Polybutene amine + solvent in rats,
Project No. 71100464, Covance Laboratories Inc, Madison, Wisconsin, USA.
Glaza S (1998b) Acute oral toxicity study of CP 2474 Polybutene amine + solvent in rats,
Project No. 71100463, Covance Laboratories Inc, Madison, Wisconsin, USA.
Glaza S (1998c) Primary dermal irritation study of CP 2474 Polybutene amine + solvent in
rabbits, Project No. 71100465, Covance Laboratories Inc, Madison, Wisconsin, USA.
Glaza S (1999d) Primary eye irritation study of CP 2474 Polybutene amine, + solvent in
rabbits, Project No. 71100466, Covance Laboratories Inc, Madison, Wisconsin, USA.
Knapp J (1999) A combined four-week repeat-dose oral toxicity, reproduction and
neurotoxicity screen in rats with CP 2474 (Polybutene amine + solvent), Project No. WIL187017, WIL Research Laboratories Inc, Ashland, OH, USA.
Lawlor T (1998) Mutagenicity test on CP 2474 (polybutene amine plus solvent)
(ID#TS97001) in the Salmonella-Escherichia coli/mammalian-microsome reverse mutation
assay with a confirmatory assay, Project No. 18980-0-409R, Covance Laboratories Inc,
Vienna, Virginia.USA.
Morris T (1998) Delayed contact hypersensitivity study with CP 2474 (Polybutene amine
plus solvent) in guinea pigs (Buehler technique), Project No. 97-8567-21, Hill Top Research
Inc., Miamiville, OH, USA.
Murli H (1998) Mutagenicity test on CP2474, Measuring chromosomal aberrations in
Chinese hamster lung (CHL) cells with a confirmatory assay with multiple harvests, Project
No. 18980-0-443Z, Covance Laboratories Inc, Vienna, Virginia, USA.
National Occupational Health and Safety Commission (1990) Occupational Diseases of the
Skin, Canberra, Australian Government Publishing Service.
National Occupational Health and Safety Commission (1994) National Code of Practice for
the Preparation of Material Safety Data Sheets [NOHSC:2011(1994)]. Canberra, Australian
Government Publishing Service.
National Occupational Health and Safety Commission (1999) Approved Criteria for
Classifying Hazardous Substances [NOHSC:1008(1999)]. Canberra, Australian Government
Publishing Service.
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Standards Australia (1978) Australian Standard 2161-1978, Industrial Safety Gloves and
Mittens (excluding electrical and medical gloves). Sydney, Standards Association of
Australia.
Standards Australia (1987) Australian Standard 2919-1987, Industrial Clothing. Sydney,
Standards Association of Australia.
Standards Australia (1990) Australian Standard 3765.1-1990, Clothing for Protection against
Hazardous Chemicals Part 1 Protection against General or Specific Chemicals. Sydney,
Standards Association of Australia.
Standards Australia (1994) Australian Standard 1336-1994, Eye protection in the Industrial
Environment. Sydney, Standards Association of Australia.
Standards Australia/Standards New Zealand (1992) Australian/New Zealand Standard 13371992, Eye Protectors for Industrial Applications. Sydney/Wellington, Standards Association
of Australia/Standards Association of New Zealand.
Standards Australia/Standards New Zealand (1994) Australian/New Zealand Standard 22101994, Occupational Protective Footwear. Sydney/Wellington, Standards Association of
Australia/Standards Association of New Zealand.
US EPA Office of Air and Radiation, Office of Mobile Sources (1994) Regulatory Impact
Analysis and Regulatory Flexibility Analysis for the Interim Detergent Registration Program
and Expected Detergent Certification Program.
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Attachment 1
The Draize Scale for evaluation of skin reactions is as follows:
Erythema Formation
Rating
Oedema Formation
Rating
No erythema
0
No oedema
0
Very slight erythema (barely perceptible)
1
Very slight oedema (barely perceptible)
1
Well-defined erythema
2
Slight oedema (edges of area welldefined by definite raising
2
Moderate to severe erythema
3
Moderate oedema (raised approx. 1 mm)
3
Severe erythema (beet redness)
4
Severe oedema (raised more than 1 mm
and extending beyond area of exposure)
4
The Draize scale for evaluation of eye reactions is as follows:
CORNEA
Opacity
Rating
Area of Cornea involved
Rating
0 none
25% or less (not zero)
1
1 slight
25% to 50%
2
Easily visible translucent areas, details
of iris slightly obscure
2 mild
50% to 75%
3
Opalescent areas, no details of iris
visible, size of pupil barely discernible
3
moderate
Greater than 75%
4
Opaque, iris invisible
4 severe
No opacity
Diffuse area, details of
visible
iris clearly
CONJUNCTIVAE
Redness
Rating
Chemosis
Rating
Discharge
Rating
Vessels normal
0 none
No swelling
0 none
No discharge
0 none
Vessels
definitely
injected above normal
1
slight
Any swelling above
normal
1
slight
Any amount different
from normal
1 slight
More diffuse, deeper
crimson
red
with
individual vessels not
easily discernible
2
Obvious swelling with
partial eversion of lids
2
mild
Discharge
with
moistening of lids and
adjacent hairs
2
3
mod.
3 severe
Discharge
with
moistening of lids and
hairs and considerable
area around eye
3 severe
Diffuse beefy red
mod.
Swelling with lids halfclosed
Swelling with lids halfclosed to completely
closed
4 severe
mod.
IRIS
Values
Rating
Normal
0 none
Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light
1 slight
No reaction to light, haemorrhage, gross destruction
2 severe
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